Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Estraimod Immediate Release (IR)
Estraimod Immediate Release · 1 trial · 1 indication
AUClast was calculated using linear/log trapezoidal method.
AUCinf was calculated as AUClast + (Clast\*/kel), where Clast is the predicted plasma concentration at the last quantifiable time point from the log-linear regression analysis, and kel is the terminal phase rate constant calculated by a linear regression of the loglinear concentration-time curve.
| Arm | Type | Description |
|---|---|---|
| Sequence 1 | EXPERIMENTAL | Single oral dose of etrasimod 2 mg clinical IR tablet under fasted conditions (Reference) followed by single oral dose of etrasimod 2 mg mini tablets mixed with applesauce under fasted conditions (Test 1) followed by single oral dose of etrasimod 2 mg mini tablets mixed with chocolate pudding under fasted conditions (Test 2) followed by single oral dose of etrasimod 2 mg mini tablets mixed with water under fasted conditions (Test 3) followed by single oral dose of etrasimod 2 mg mini tablets mixed with yogurt under fasted conditions (Test 4) |
| Sequence 2 | EXPERIMENTAL | Single oral dose of etrasimod 2 mg mini tablets mixed with applesauce under fasted conditions (Test 1) followed by single oral dose of etrasimod 2 mg mini tablets mixed with water under fasted conditions (Test 3) followed by single oral dose of etrasimod 2 mg clinical IR tablet under fasted conditions (Reference) followed by single oral dose of etrasimod 2 mg mini tablets mixed with chocolate pudding under fasted conditions (Test 2) followed by single oral dose of etrasimod 2 mg mini tablets mixed with yogurt under fasted conditions (Test 4) |
| Sequence 3 | EXPERIMENTAL | Single oral dose of etrasimod 2 mg mini tablets mixed with chocolate pudding under fasted conditions (Test 2). Followed by single oral dose of etrasimod 2 mg clinical IR tablet under fasted conditions (Reference).followed by single oral dose of etrasimod 2 mg mini tablets mixed with water under fasted conditions (Test 3). Followed by single oral dose of etrasimod 2 mg mini tablets mixed with applesauce under fasted conditions (Test 1) Followed by single oral dose of etrasimod 2 mg mini tablets mixed with yogurt under fasted conditions (Test 4) |
| Sequence 4 | EXPERIMENTAL | Single oral dose of etrasimod 2 mg mini tablets mixed with water under fasted conditions (Test 3). Followed by single oral dose of etrasimod 2 mg mini tablets mixed with chocolate pudding under fasted conditions (Test 2). Followed by single oral dose of etrasimod 2 mg mini tablets mixed with applesauce under fasted conditions (Test 1). Followed by single oral dose of etrasimod 2 mg clinical IR tablet under fasted conditions (Reference). Followed by single oral dose of etrasimod 2 mg mini tablets mixed with yogurt under fasted conditions (Test 4) |
| Name | Type | Description |
|---|---|---|
| Estraimod Immediate Release (IR) | DRUG | an immediate release tablet |
| Etrasimod Mini Tab in water | DRUG | very small tablet mixed in water |
| Etrasimod Mini Tab in chocolate pudding | DRUG | very small tablet mixed in chocolate pudding |
| Etrasimod Mini Tab in yogurt | DRUG | Very small tablet mixed in yogurt |
| Etrasimod Mini Tab in applesauce | DRUG | Very small tablet mixed in applesauce |
Inclusion Criteria: * Healthy participants * BMI 16 to 32 kg/m2 * body weight more than 50kg Exclusion Criteria: * Ongoing or past history of significant medical conditions * Eye disorders such as macular edema or uveitis * Ongoing or recent infections * Use of prescription or non prescription me...
Estraimod Immediate Release is an investigational small molecule developed by Pfizer, Inc. (ticker PFE). It is in Phase 1 clinical development. The specific therapeutic indications for this asset have not been publicly disclosed, and it falls within the broader therapeutic area classified as Other.
Estraimod Immediate Release is being developed by Pfizer, Inc., which trades under the ticker symbol PFE. Pfizer is the sponsor responsible for the clinical program, including the Phase 1 study that has been completed for this asset.
Estraimod Immediate Release is in Phase 1 clinical development. It is an investigational small molecule and has not been approved by the FDA. The program includes one completed Phase 1 trial, with no active trials currently listed.
Estraimod Immediate Release has been studied in one completed Phase 1 trial, NCT05956002, titled "A Study to Evaluate the Study Medication (Etrasimod) When Mixed With Food in Healthy Participants." The trial enrolled 16 healthy participants in Belgium and was randomized and controlled.
Yes, Estraimod Immediate Release is also known as Estraimod Immediate Release (IR). The abbreviation IR stands for immediate release, which refers to the formulation type. Both names refer to the same investigational asset developed by Pfizer, Inc.